Statistical Programmer

Statistical Programmer Remote

Duration: 12+ Months

Rate: DOE

Key responsibilities

1. At least 5 years of experience in ADaM/TLF.
2. Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverables
3. Develop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in production side.
4. Collaborate with statisticians and data managers to define dataset specifications and outputs
5. Ensure compliance with internal SOPs, CDISC standards, and regulatory requirements
6. Conduct quality control checks and peer reviews of programming code and study outputs
7. Support submission activities including eCTD and regulatory responses as needed
8. Document programming activities and maintain clear audit trails
9. Has experience on the safety ADaM/TLF production side instead of validation side
10. Has experience leading pivotal studies (phase 2, phase 3 studies).
11. Strong proficiency in SAS programming (Base, Macro, SQL); familiarity with R or Python is a plus
12. Develop study protocols, statistical analysis plans (SAPs), and define analysis datasets
13. Understanding of CDISC standards (SDTM, ADaM)
14. Knowledge of FDA/EMA regulatory requirements and e-submission standards
15. Excellent problem-solving and communication skills
16. Experience with oncology, rare diseases, or global trials
17. Exposure to automation tools or advanced data visualization techniques
18. Ability to mentor junior programmers or lead small projects